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The aim of this study is to compare the quality of recovery in patients undergoing arthroscopic shoulder surgery depending on the type of anesthesia used:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator | The patient undergoes shoulder arthroscopy under general anesthesia after receiving a preoperative brachial plexus block for intra- and postoperative analgesia. |
|
| Brachial plexus block | Experimental | The patient undergoes shoulder arthroscopy under brachial plexus block and intraoperative sedation with remimazolam or propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brachial Plexus Block | Procedure | Interscalene brachial plexus block with 0.75% ropivacaine. Intraoperative sedation with remimazolam or propofol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of recovery (QoR-15) at 48 hours post-surgery | Quality of recovery (QoR-15) at 48 hours post-surgery (0-150) | at 48 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Antiemetic administration | Antiemetic administration from end of surgery up to 48 hours post-surgery | rom end of surgery up to 48 hours post-surgery |
| Baseline hemidiagphramatic paralysis | Baseline hemidiagphramatic paralysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hansol Kim, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 03080 | South Korea |
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| ID | Term |
|---|---|
| D065527 | Brachial Plexus Block |
| D000768 | Anesthesia, General |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D009407 | Nerve Block |
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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Parallel group, open-label randomized trial
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| General Anesthesia (control group) | Procedure | General anesthesia with propofol, fentanyl and rocuronium for induction, and with sevoflurane for maintenance. Brachial plexus block with 0.5% ropivacaine for intra- and postoperative analgesia. |
|
| On the day of surgery, before the operation |
| Postoperative hemidiagphramatic paralysis | Postoperative hemidiagphramatic paralysis | Immediately after surgery |
| Quality of recovery (QoR-15) on the day before surgery | Quality of recovery (QoR-15) on the day before surgery (0-150) | on the day before surgery |
| Quality of recovery (QoR-15) 24 hours post-surgery | Quality of recovery (QoR-15) 24 hours post-surgery (0-150) | at 24 hours post-surgery |
| Postoperative pain 1 hour post-surgery | Postoperative pain 1 hour post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) | at 1 hour post-surgery |
| Postoperative pain 6 hours post-surgery | Postoperative pain 6 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) | at 6 hours post-surgery |
| Postoperative pain 12 hours post-surgery | Postoperative pain 12 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) | at 12 hours post-surgery |
| Postoperative pain 24 hours post-surgery | Postoperative pain 24 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) | at 24 hours post-surgery |
| Postoperative pain 48 hours post-surgery | Postoperative pain 48 hours post-surgery (Numeric rating scale, 0: no pain; 10: worst pain imaginable) | at 48 hours post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 1 hour post-surgery | at 1 hour post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 6 hours post-surgery | at 6 hours post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 12 hours post-surgery | at 12 hours post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 24 hours post-surgery | at 24 hours post-surgery |
| Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery | Incidence of postoperative nausea and/or vomiting (PONV) 48 hours post-surgery | at 48 hours post-surgery |
| Rescue opioid analgesic administration | Rescue opioid analgesic administration from end of surgery up to 48 hours post-surgery (morphine milligram equivalent, MME) | from end of surgery up to 48 hours post-surgery |
| D015340 |
| Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |